Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma

May 12, 2022 updated by: Breanna Willeford, University of Alabama at Birmingham
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.

Study Overview

Detailed Description

Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Highlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. subjects between ages 19 to 75, both male and female
  2. radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
  3. Failed a trial of physical therapy of at least 4 weeks

Exclusion Criteria:

  1. Full thickness tears (well documented need for surgical correction)
  2. sensory or neurologic complaint affecting the shoulder of interest
  3. Coagulation disorder, platelet disorder
  4. Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
  5. Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
  6. Prior surgery to either cervical spine or shoulder
  7. Active military
  8. Injury part of worker compensation claim

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRP injection into PTRCT
Treatment - PRP injection

Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.

PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.

Other Names:
  • Biologics
Active Comparator: Subacromial steroid bursal injection
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
Other Names:
  • Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Ultrasound
Time Frame: 6 months post procedure

Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.

Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.

6 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index
Time Frame: Week 3 post procedure SPADI Scores for the control and treatment groups.

Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.

In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.

2 participants in the control (corticosteroid injection) group completed the study.

Week 3 post procedure SPADI Scores for the control and treatment groups.
Shoulder Pain and Disability Index
Time Frame: Week 6 post procedure SPADI Scores for the treatment and control groups.

Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.

In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.

2 participants in the control (corticosteroid injection) group completed the study.

Week 6 post procedure SPADI Scores for the treatment and control groups.
Shoulder Pain and Disability Index
Time Frame: 6 months post procedure SPADI scores for the treatment and control groups.

Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.

In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.

2 participants in the control (corticosteroid injection) group completed the study.

6 months post procedure SPADI scores for the treatment and control groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Breanna Willeford, DO, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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